OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5

K140226 · Science For Biomaterials · HRS · Jun 3, 2014 · Orthopedic

Device Facts

• Record ID: K140226
• Device Name: OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5
• Applicant: Science For Biomaterials
• Product Code: HRS · Orthopedic
• Decision Date: Jun 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NEOTIS Plate is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.

Device Story

NEOTIS Plate and Screws system designed for medial approach high tibial osteotomy stabilization. Anatomically shaped, thin, short plate enables minimally invasive surgery. System replaces proximal temporary screw with pin for simpler/faster placement and reduced cortical bone drilling; replaces distal temporary screw with AO screw to maintain compression. Compression maintained by four permanent 6.5 mm OTIS screws. Used by orthopedic surgeons in clinical settings. Provides bone fixation to stabilize osteotomy site, benefiting patient through improved surgical efficiency and maintained compression.

Clinical Evidence

No clinical data presented. Non-clinical performance testing includes a cadaver study confirming the level of compression induced during plate placement.

Technological Characteristics

Metallic bone fixation plate and screws. Anatomically shaped, thin, short form factor. Mechanical properties identical to predicate. No software or electronic components.

Indications for Use

Indicated for patients undergoing proximal tibial opening wedge osteotomies requiring bone fixation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• OTIS-C Plus Plate Fixation System (K100604)
• OTIS-C Plus Plate Fixation System (K120818)

Submission Summary (Full Text)

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Traditional 510(k) NEOTIS System

Image /page/0/Picture/1 description: The image shows the letters SBM in bold, black font. Below the letters is the phrase "Science & Bio Materials" in a smaller font. To the right of the letters are three right-pointing triangles. The first triangle is gray, the second is black, and the third is white.

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K140226 page 1 of 2

JUN 0 3 2014

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### 510(k) SUMMARY

As required by section 807.92

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### 1. GENERAL INFORMATION

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| Type of 510(k) | TRADITIONAL |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | NEOTIS Plate and Screws |
| CFR section | 21CFR 888.3030 |
| Classification Name | Single/multiple component metallic bone fixation appliances<br>and accessories |
| Device panel | ORTHOPEDIC |
| Product Code | HRS: PLATE, FIXATION, BONE<br>HWC : SCREW, FIXATION, BONE |
| Class | II |
| Legally marketed<br>predicate devices | K100604 and K120818 OTIS-C Plus® Plate Fixation System<br>manufactured by SBM Sciences for Bio Materials. |
| Submitter | SCIENCE FOR BIOMATERIALS<br>Sciences et Bio Matériaux<br>ZI du Monge<br>F 65100 LOURDES - FRANCE<br>Registration Number : 3004549189 |
| Contact | Denis CLEMENT, CEO<br>Tel : [phone]<br>Fax : [phone]<br>e-mail : [e-mail]<br>Regulatory contact : Anne COSPIN-LATAPIE<br>[e-mail] |

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#### Traditional 510(k) NEOTIS System

K140226 page 2 of 2

#### 2. DEVICE DESCRIPTION

The NEOTIS plate is designed for medial approach High Tibial Osteotomy stabilization. Anatomically shaped, thin and short, the NEOTIS plate enables minimally invasive surgery. The changes brought by the NEOTIS plate are as follows (vs. OTIS-C Plus plate):

- The proximal temporary screw is replaced with a pin that offers a simpler and faster placement of the plate. The area of the cortical bone drilled through the process is also reduced.

- The distal temporary screw is replaced with an AO screw in order to maintain compression. The compression will be maintained by the 4 permanent 6.5 mm screws (OTIS screws).

#### 3. INDICATIONS FOR USE

NEOTIS plate is intended to be used in conjunction with OTIS screws to provide fixation following Proximal Tibial opening wedge osteotomies.

#### 4. PERFORMANCE DATA ·

The mechanical properties are the same as for the previous OTIS-C Plus, the only changes occur during the placement of the plate. No clinical data has been presented. Non-clinical performance testing includes a cadaver study that confirms the level of compression induced during the placement of the plate.

#### 5. SUBSTANTIAL EQUIVALENCE

The NEOTIS plate is substantially equivalent to its predicate device OTIS-C Plus plate (K100604 and K120818). Verification and validation tests demonstrate that modified the NEOTIS plate is as safe, as effective, and performs as safely and effectively as its predicate device.

Summary preparation date: June 2, 2014

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2014

Science for Biomaterials (Sciences et Bio Matériaux) Mr. Denis Clement General Manager ZI du Monge F 65100 Lourdes - FRANCE

Re: K140226

Trade/Device Name: NEOTIS Plate and Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 11, 2014 Received: April 14, 2014

Dear Mr. Clement:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Mr. Denis Clement

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default,htm.

Sincerely yours,

## Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) NEOTIS Plate

## SBM

#### INDICATIONS FOR USE

510(k) Number (if known): K140226 Device Name: NEOTIS Plate and Screws Indications for Use:

NEOTIS Plate is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.

AND/OR

Prescription Use く (Part 21 CFR 801 Subpart D)

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Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabet标验厂rank -S

Division of Orthopedic Devices